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Paper of the Month February 2011

Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males

The New England Journal of Medicine, Feb 3, 2011, 364(5):401-411


Anna R. Giuliano, Joel M. Palefsky, Stephen Goldstone, Edson D. Moreira, Jr., Mary E. Penny, Carlos Aranda, Eftyhia Vardas, Harald Moi, Heiko Jessen, Richard Hillman, Yen-Hwa Chang, Daron Ferris, Danielle Rouleau, Janine Bryan, J. Brooke Marshall, Scott Vuocolo, Eliav Barr, David Radley, Richard M. Haupt and Dalya Guris

Related “Perspective” from Dr. Jane J. Kim

Weighing the benefits and costs of HPV vaccination of young men

The New England Journal of Medicine, Feb. 3, 2011, 364(5):393-395


Though the evidence regarding the efficacy of the HPV vaccines to this point has centered on the prevention of HPV infection and diseases in girls and women, the data presented by Giuliano et al. in this issue of the Journal (pages 401–411) affirm the potential for HPV vaccines to prevent related disease in boys and men. The investigators report the efficacy of the quadrivalent HPV vaccine in preventing infections with the HPV types included in the vaccine, as well as external genital lesions, primarily genital warts, in young men 16 to 26 years of age.”

These data informed the 2009 approval by the Food and Drug Administration (FDA) of the quadrivalent HPV vaccine for the prevention of genital warts in young men in the United States and the subsequent recommendation from the Advisory Committee on Immunization Practices (ACIP), which advises the Centers for Disease Control and Prevention (CDC), for the permissive use of the vaccine in boys and young men 9 to 26 years of age. The ACIP stopped short of supporting routine HPV vaccination of adolescent boys, even though routine vaccination of girls between the ages of 11 and 12 years (and as early as 9 years) has been recommended since 2007. However, the committee did recommend financial coverage by the CDC Vaccines for Children program for eligible boys 18 years of age or younger. Since these decisions were made, newer data have shown that the quadrivalent HPV vaccine is effective in preventing anal intraepithelial neoplasia, a precursor to anal cancer, in men, particularly in men who have sex with men. Q, the basis of this new evidence, the FDA recently approved the expanded use of the quadrivalent vaccine to include the prevention of anal lesions and cancer in people of both sexes, a decision that has reignited the debate over routine HPV vaccination of young men.”

The report by Giuliano et al. undoubtedly gives us cause to celebrate the extraordinary potential for HPV vaccination to improve health in both women and men. And although enthusiasm for universal vaccination may initially be tempered by uncertainties about the vaccine’s safety, efficacy, and duration of protection (as well as its uptake, acceptability, and cost), many of these factors could very well change in the future. For example, the cost effectiveness profile of routine vaccination of young men will improve if the evidence of efficacy continues to mount, the vaccine price declines, or coverage among girls and women remains low.